Department of Paediatric and Child Health and INFANT Research Centre, University College Cork, Cork, Ireland
Néonatologie, Centre Hospitalier Universitaire Sainte Justine, Montreal, Quebec, Canada.
Arch Dis Child Fetal Neonatal Ed. 2021 Jul;106(4):398-403. doi: 10.1136/archdischild-2020-320241. Epub 2021 Feb 24.
To determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation.
Double-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment.
10 sites across Europe and Canada.
Infants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for ≥15 min in the first 72 hours of life and a cerebral ultrasound free of significant (≥ grade 3) intraventricular haemorrhage.
Participants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management).
Survival to 36 weeks of PMA without severe brain injury.
The trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038).
Though this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area.
NCT01482559, EudraCT 2010-023988-17.
确定在出生后 28 周前出生的婴儿生命的最初 72 小时内低血压（BP）诊断后限制使用儿茶酚胺类药物是否会影响出生后 36 周的无显著脑损伤的存活率。
双盲、安慰剂对照随机试验。护理人员对分组情况进行了设盲。
欧洲和加拿大的 10 个地点。
如果婴儿在生命的最初 72 小时内存在持续时间超过 15 分钟的、与胎龄相关的侵入性平均血压降低，且大脑超声无显著（≥3 级）脑室内出血，那么出生于 28 周之前的婴儿有资格参与本研究。
参与者被随机分配接受盐水冲击，然后接受多巴胺输注（标准治疗）或安慰剂（5%葡萄糖）输注（限制治疗）。
出生后 36 周的无严重脑损伤的存活率。
由于入组人数不足（计划入组人数的 7.7%），该试验提前终止。2015 年 2 月至 2017 年 9 月期间共纳入了 58 名婴儿。两组在基线变量方面匹配良好。在标准组中，29 名婴儿中有 18 名（62%）达到了主要结局，而限制组中有 29 名婴儿中的 20 名（69%）达到了主要结局（p=0.58）。在标准组中，较少频繁地使用了用于治疗低血压的其他药物（29 名婴儿中的 11 名[38%]与 29 名婴儿中的 19 名[66%]相比，p=0.038）。
尽管本研究缺乏效力，但我们没有发现标准治疗或限制治疗方法在临床结局方面的主要差异。这些结果将为该领域的未来研究提供信息。
NCT01482559，EudraCT 2010-023988-17。
